Free Articles Directory Sudan: May 2012

Thursday, 31 May 2012

Diamicron 30 mg MR

1. Name Of The Medicinal Product

DIAMICRON 30 mg MR Tablets

2. Qualitative And Quantitative Composition

One tablet contains gliclazide 30 mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Modified release tablet.

White, oblong tablet engraved on both faces, 'DIA 30' on one face and

4. Clinical Particulars

4.1 Therapeutic Indications

Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.

4.2 Posology And Method Of Administration

Oral use.

For adult use only.

The daily dose may vary from 1 to 4 tablets per day, i.e. from 30 to 120 mg taken orally in a single intake at breakfast time.

It is recommended that the tablet(s) be swallowed whole.

If a dose is forgotten, there must be no increase in the dose taken the next day.

As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbAlc)

• Initial dose

The recommended starting dose is 30 mg daily.

If blood glucose is effectively controlled, this dose may be used for maintenance treatment.

If blood glucose is not adequately controlled, the dose may be increased to 60, 90 or 120 mg daily, in successive steps. The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment.

The maximum recommended daily dose is 120 mg.

• Switching from Diamicron 80 mg tablets to Diamicron 30 mg modified release tablets:

1 tablet of Diamicron 80 mg is comparable to 1 tablet of Diamicron 30 mg MR Tablets. Consequently the switch can be performed provided a careful blood monitoring.

• Switching from another oral antidiabetic agent to Diamicron 30 mg MR Tablets:

Diamicron 30 mg MR Tablets can be used to replace other oral antidiabetic agents.

The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to Diamicron 30 mg MR Tablets.

A transitional period is not generally necessary. A starting dose of 30 mg should be used and this should be adjusted to suit the patient's blood glucose response, as described above.

When switching from a hypoglycaemic sulphonylurea with a prolonged half-life, a treatment free period of a few days may be necessary to avoid an additive effect of the two products, which might cause hypoglycaemia. The procedure described for initiating treatment should also be used when switching to treatment with Diamicron 30 mg MR Tablets, i.e. a starting dose of 30 mg/day, followed by a stepwise increase in dose, depending on the metabolic response.

• Combination treatment with other antidiabetic agents:

Diamicron 30 mg MR Tablets can be given in combination with biguanides, alpha glucosidase inhibitors or insulin.

In patients not adequately controlled with Diamicron 30 mg MR Tablets, concomitant insulin therapy can be initiated under close medical supervision.

• In the elderly (over 65), Diamicron 30 mg MR Tablets should be prescribed using the same dosing regimen recommended for patients under 65 years of age. In patients with mild to moderate renal insufficiency the same dosing regimen can be used as in patients with normal renal function with careful patient monitoring. These data have been confirmed in clinical trials.

• In patients at risk of hypoglycaemia:

- undernourished or malnourished,

- severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotrophic insufficiency),

- withdrawal of prolonged and/or high dose corticosteroid therapy,

- severe vascular disease (severe coronary heart disease, severe carotid impairment, diffuse vascular disease);

It is recommended that the minimum daily starting dose of 30 mg is used.

• There are no data and clinical studies available in children.

4.3 Contraindications

• known hypersensitivity to gliclazide or to any of the excipients, other sulphonylureas, sulphonamides,

• type 1 diabetes,

• diabetic pre-coma and coma, diabetic keto-acidosis,

• severe renal or hepatic insufficiency: in these cases the use of insulin is recommended,

• treatment with miconazole (see Section "Interactions with other medicinal products and other forms of interaction"),

• lactation (see Section "Pregnancy and Lactation").

4.4 Special Warnings And Precautions For Use

HYPOGLYCAEMIA:

This treatment should be prescribed only if the patient is likely to have a regular food intake (including breakfast). It is important to have a regular carbohydrate intake due to the increased risk of hypoglycaemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate. Hypoglycaemia is more likely to occur during low-calorie diets, following prolonged or strenuous exercise, alcohol intake or if a combination of hypoglycaemic agents is being used.

Hypoglycaemia may occur following administration of sulphonylureas (see 4.8. Undesirable effects). Some cases may be severe and prolonged. Hospitalisation may be necessary and glucose administration may need to be continued for several days.

Careful selection of patients, of the dose used, and clear patient directions are necessary to reduce the risk of hypoglycaemic episodes.

Factors which increase the risk of hypoglycaemia:

• patient refuses or (particularly in elderly subjects) is unable to co-operate,

• malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary changes,

• imbalance between physical exercise and carbohydrate intake,

• renal insufficiency,

• severe hepatic insufficiency,

• overdose of Diamicron 30 mg MR Tablets,

• certain endocrine disorders: thyroid disorders, hypopituitarism and adrenal insufficiency,

• concomitant administration of certain other medicines (see Interactions).

Renal and hepatic insufficiency: the pharmacokinetics and/or pharmacodynamics of gliclazide may be altered in patients with hepatic insufficiency or severe renal failure. A hypoglycaemic episode occurring in these patients may be prolonged, so appropriate management should be initiated.

Patient information:

The risks of hypoglycaemia, together with its symptoms, treatment, and conditions that predispose to its development, should be explained to the patient and to family members.

The patient should be informed of the importance of following dietary advice, of taking regular exercise, and of regular monitoring of blood glucose levels.

Poor blood glucose control: blood glucose control in a patient receiving antidiabetic treatment may be affected by any of the following: fever, trauma, infection or surgical intervention. In some cases, it may be necessary to administer insulin.

The hypoglycaemic efficacy of any oral antidiabetic agent, including gliclazide, is attenuated over time in many patients: this may be due to progression in the severity of the diabetes, or to a reduced response to treatment. This phenomenon is known as secondary failure which is distinct from primary failure, when an active substance is ineffective as first-line treatment. Adequate dose adjustment and dietary compliance should be considered before classifying the patient as secondary failure.

Laboratory tests: Measurement of glycated haemoglobin levels (or fasting venous plasma glucose) is recommended in assessing blood glucose control. Blood glucose self-monitoring may also be useful.

Treatment of patients with G6PD-deficiency with sulphonylurea agents can lead to haemolytic anaemia. Since gliclazide belongs to the chemical class of sulphonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulphonylurea alternative should be considered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

1) The following products are likely to increase the risk of hypoglycaemia

Contra-indicated combination

• Miconazole (systemic route, oromucosal gel): increases the hypoglycaemic effect with possible onset of hypoglycaemic symptoms, or even coma.

Combinations which are not recommended

• Phenylbutazone (systemic route): increases the hypoglycaemic effect of sulphonylureas (displaces their binding to plasma proteins and/or reduces their elimination).

It is preferable to use a different anti-inflammatory agent, or else to warn the patient and emphasise the importance of self-monitoring. Where necessary, adjust the dose during and after treatment with the anti-inflammatory agent.

• Alcohol: increases the hypoglycaemic reaction (by inhibiting compensatory reactions) that can lead to the onset of hypoglycaemic coma.

Avoid alcohol or medicines containing alcohol.

Combinations requiring precautions for use

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when one of the following drugs is taken, for example:

Other anti-diabetic agents (insulins, acarbose, biguanides), beta-blockers, fluconazole, angiotensin converting enzyme inhibitors (captopril, enalapril), H2-receptor antagonists, MAOIs, sulphonamides, and non-steroidal anti-inflammatory agents.

2) The following products may cause an increase in blood glucose levels

Combination which is not recommended

• Danazol: diabetogenic effect of danazol.

If the use of this active substance cannot be avoided, warn the patient and emphasise the importance of urine and blood glucose monitoring. It may be necessary to adjust the dose of the antidiabetic agent during and after treatment with danazol.

Combinations requiring precautions during use

• Chlorpromazine (neuroleptic agent): high doses (>100 mg per day of chlorpromazine) increase blood glucose levels (reduced insulin release).

Warn the patient and emphasise the importance of blood glucose monitoring. It may be necessary to adjust the dose of the antidiabetic active substance during and after treatment with the neuroleptic agent.

• Glucocorticoids (systemic and local route: intra-articular, cutaneous and rectal preparations) and tetracosactrin: increase in blood glucose levels with possible ketosis (reduced tolerance to carbohydrates due to glucocorticoids).

Warn the patient and emphasise the importance of blood glucose monitoring, particularly at the start of treatment. It may be necessary to adjust the dose of the antidiabetic active substance during and after treatment with glucocorticoids.

• Ritodrine, salbutamol, terbutaline: (I.V.)

Increased blood glucose levels due to beta-2 agonist effects.

Emphasise the importance of monitoring blood glucose levels. If necessary, switch to insulin.

3) Combination which must be taken into account

• Anticoagulant therapy (Warfarin ...):

Sulphonylureas may lead to potentiation of anticoagulation during concurrent treatment.

Adjustment of the anticoagulant may be necessary.

4.6 Pregnancy And Lactation

Pregnancy

There is no experience with the use of gliclazide during pregnancy in humans, even though there are few data with other sulphonylureas.

In animal studies, gliclazide is not teratogenic.

Control of diabetes should be obtained before the time of conception to reduce the risk of congenital abnormalities linked to uncontrolled diabetes.

Oral hypoglycaemic agents are not suitable, insulin is the drug of first choice for treatment of diabetes during pregnancy. It is recommended that oral hypoglycaemic therapy is changed to insulin before a pregnancy is attempted, or as soon as pregnancy is discovered.

Lactation

It is not known whether gliclazide or its metabolites are excreted in breast milk. Given the risk of neonatal hypoglycaemia, the product is contra-indicated in breast-feeding mothers.

4.7 Effects On Ability To Drive And Use Machines

Patients should be made aware of the symptoms of hypoglycaemia and should be careful if driving or operating machinery, especially at the beginning of treatment.

4.8 Undesirable Effects

Based on the experience with gliclazide and with other sulphonylureas, the following undesirable effects have to be mentioned.

Hypoglycaemia

As for other sulphonylureas, treatment with Diamicron 30 mg MR Tablets can cause hypoglycaemia, if mealtimes are irregular and, in particular, if meals are skipped. Possible symptoms of hypoglycaemia are: headache, intense hunger, nausea, vomiting, lassitude, sleep disorders, agitation, aggression, poor concentration, reduced awareness and slowed reactions, depression, confusion, visual and speech disorders, aphasia, tremor, paresis, sensory disorders, dizziness, feeling of powerlessness, loss of self-control, delirium, convulsions, shallow respiration, bradycardia, drowsiness and loss of consciousness, possibly resulting in coma and lethal outcome.

In addition, signs of adrenergic counter-regulation may be observed: sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris and cardiac arrhythmia.

Usually, symptoms disappear after intake of carbohydrates (sugar). However, artificial sweeteners have no effect. Experience with other sulphonylureas shows that hypoglycaemia can recur even when measures prove effective initially.

If a hypoglycaemic episode is severe or prolonged, and even if it is temporarily controlled by intake of sugar, immediate medical treatment or even hospitalisation are required.

Gastrointestinal disturbances, including abdominal pain, nausea, vomiting dyspepsia, diarrhoea, and constipation have been reported: if these should occur they can be avoided or minimised if gliclazide is taken with breakfast.

The following undesirable effects have been more rarely reported:

• Skin and subcutaneous tissue disorders: rash, pruritus, urticaria, erythema, maculopapular rashes, bullous reactions.

• Blood and lymphatic system disorders: Changes in haematology are rare. They may include anaemia, leucopenia, thrombocytopenia, granulocytopenia. These are in general reversible upon discontinuation of medication.

• Hepato-biliary disorders: raised hepatic enzyme levels (AST, ALT, alkaline phosphatase), hepatitis (isolated reports). Discontinue treatment if cholestatic jaundice appears.

These symptoms usually disappear after discontinuation of treatment.

• Eye disorders

Transient visual disturbances may occur especially on initiation of treatment, due to changes in blood glucose levels.

• Class attribution effects:

Cases of erythrocytopenia, agranulocytosis, haemolytic anaemia, pancytopenia and allergic vasculitis, have been described for other sulphonylureas.

With other sulphonylureas cases were also observed of elevated liver enzyme levels and even impairment of liver function (e.g. with cholestasis and jaundice) and hepatitis which regressed after withdrawal of the sulphonylurea or led to life-threatening liver failure in isolated cases.

4.9 Overdose

An overdose of sulphonylureas may cause hypoglycaemia.

Moderate symptoms of hypoglycaemia, without any loss of consciousness or neurological signs, must be corrected by carbohydrate intake, dose adjustment and/or change of diet. Strict monitoring should be continued until the doctor is sure that the patient is out of danger.

Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders are possible and must be treated as a medical emergency, requiring immediate hospitalisation.

If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid I.V. injection of 50 mL of concentrated glucose solution (20 to 30 %). This should be followed by continuous infusion of a more dilute glucose solution (10 %) at a rate that will maintain blood glucose levels above 1 g/L. Patients should be monitored closely and, depending on the patient's condition after this time, the doctor will decide if further monitoring is necessary.

Dialysis is of no benefit to patients due to the strong binding of gliclazide to proteins.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

SULFONAMIDES, UREA DERIVATIVES

ATC code: A10BB09

Gliclazide is a hypoglycaemic sulphonylurea oral antidiabetic active substance differing from other related compounds by an N-containing heterocyclic ring with an endocyclic bond.

Gliclazide reduces blood glucose levels by stimulating insulin secretion from the β-cells of the islets of Langerhans. Increase in postprandial insulin and C-peptide secretion persists after two years of treatment.

In addition to these metabolic properties, gliclazide has haemovascular properties.

Effects on insulin release

In type 2 diabetics, gliclazide restores the first peak of insulin secretion in response to glucose and increases the second phase of insulin secretion. A significant increase in insulin response is seen in response to stimulation induced by a meal or glucose.

Haemovascular properties:

Gliclazide decreases microthrombosis by two mechanisms which may be involved in complications of diabetes:

• a partial inhibition of platelet aggregation and adhesion, with a decrease in the markers of platelet activation (beta thromboglobulin, thromboxane B₂).

• an action on the vascular endothelium fibrinolytic activity with an increase in tPA activity.

5.2 Pharmacokinetic Properties

Plasma levels increase progressively during the first 6 hours, reaching a plateau which is maintained from the sixth to the twelfth hour after administration.

Intra-individual variability is low.

Gliclazide is completely absorbed. Food intake does not affect the rate or degree of absorption.

The relationship between the dose administered ranging up to 120 mg and the area under the concentration time curve is linear.

Plasma protein binding is approximately 95%.

Gliclazide is mainly metabolised in the liver and excreted in the urine: less than 1% of the unchanged form is found in the urine. No active metabolites have been detected in plasma.

The elimination half-life of gliclazide varies between 12 and 20 hours.

The volume of distribution is around 30 litres.

No clinically significant changes in pharmacokinetic parameters have been observed in elderly patients.

A single daily dose of Diamicron 30 mg MR Tablets maintains effective gliclazide plasma concentrations over 24 hours.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazards for humans based on conventional studies of repeated dose toxicity and genotoxicity. Long term carcinogenicity studies have not been done. No teratogenic changes have been shown in animal studies, but lower fœtal body weight was observed in animals receiving doses 25 fold higher than the maximum recommended dose in humans.

6. Pharmaceutical Particulars

6.1 List Of Excipients

CALCIUM HYDROGEN PHOSPHATE DIHYDRATE,

MALTODEXTRIN,

HYPROMELLOSE,

MAGNESIUM STEARATE,

ANHYDROUS COLLOIDAL SILICA.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 112, 120, 180 and 500 tablets in Aluminium/Poly(vinylchloride) blister, packed in cardboard boxes.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Les Laboratoires Servier

22, rue Garnier

92200 Neuilly Sur Seine

France

8. Marketing Authorisation Number(S)

PL 05815/0019

9. Date Of First Authorisation/Renewal Of The Authorisation

05/03/2010

10. Date Of Revision Of The Text

March 2010

Apidra OptiClik Cartridge

Generic Name: insulin glulisine (IN su lin GLOO lis een)

Brand Names: Apidra, Apidra OptiClik Cartridge, Apidra SoloStar Pen

What is Apidra OptiClik Cartridge (insulin glulisine)?

Insulin glulisine is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin glulisine is a faster-acting form of insulin than regular human insulin.

Insulin glulisine is used to treat diabetes in adults and children who are at least 4 years old. It is usually given together with a long-acting insulin.

Insulin glulisine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Apidra OptiClik Cartridge (insulin glulisine)?

Insulin glulisine is a fast-acting insulin that begins to work very quickly. You should use it within 15 minutes before or 20 minutes after you start eating a meal.

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Insulin glulisine is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

What should I discuss with my healthcare provider before using Apidra OptiClik Cartridge (insulin glulisine)?

Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Before using insulin glulisine, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, including any oral (taken by mouth) diabetes medications.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

FDA pregnancy category C. It is not known whether insulin glulisine is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether insulin glulisine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Apidra OptiClik Cartridge (insulin glulisine)?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Insulin glulisine is given as an injection (shot) under your skin using a needle and syringe, an injection pen, or an insulin pump. It may also be given through a needle placed into a vein. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Insulin glulisine is a fast-acting insulin that begins to work very quickly. You should use it within 15 minutes before or 20 minutes after you start eating a meal.

Insulin glulisine should be thin, clear, and colorless. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.

If you use this medication with an insulin pump, do not mix or dilute insulin glulisine with any other insulin. Call your doctor at once if you think your infusion pump is not working properly.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.

Infusion pump tubing, catheters, and the needle location on your skin should be changed every 48 hours.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, or skip meals. These things can affect your glucose levels and your insulin dose needs may also change.

Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Ask your doctor how to adjust your insulin glulisine dose if needed. Do not change your dose without first talking to your doctor. Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic. Storing unopened vials, cartridges, or injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any insulin not used before the expiration date on the medicine label. Unopened vials, cartridges, or injection pens may also be stored at room temperature for up to 28 days, away from heat and bright light. Throw away any insulin not used within 28 days.

Storing after your first use: You may keep "in-use" vials in the refrigerator or at room temperature, protected from light. Use within 28 days.

In-use cartridges or injection pens must be stored at room temperature, away from heat and bright light. Do not refrigerate an in-use cartridge or injection pen. Keep it at room temperature and use within 28 days. An infusion set should be stored at room temperature and used within 48 hours.

Do not freeze insulin glulisine, and throw away the medication if it has become frozen.

What happens if I miss a dose?

Since insulin glulisine is used before meals, you may not be on a timed dosing schedule. Whenever you use insulin glulisine, be sure to eat a meal within 15 minutes. Do not use extra insulin glulisine to make up a missed dose.

It is important to keep insulin glulisine on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.

What should I avoid while using Apidra OptiClik Cartridge (insulin glulisine)?

Do not change the brand of insulin glulisine or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin glulisine. Do not expose insulin glulisine to high heat. Throw the medication away if it becomes hotter than 98 degrees F.

Apidra OptiClik Cartridge (insulin glulisine) side effects

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin glulisine. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Insulin glulisine can also cause hypokalemia (low potassium levels in the blood). Call your doctor at once if you have symptoms such as dry mouth, increased thirst, increased urination, uneven heartbeats, muscle pain or weakness, leg pain or discomfort, or confusion.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin glulisine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Apidra OptiClik Cartridge (insulin glulisine)?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

albuterol (Proventil, Ventolin);

clonidine (Catapres);

guanethidine (Ismelin);

lanreotide (Somatuline Depot);

niacin (Niaspan, Niacor, Advicor);

octreotide (Sandostatin);

pramlintide (Symlin);

reserpine;

beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others.

There are many other medicines that can increase or decrease the effects of insulin glulisine on lowering your blood sugar. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Apidra OptiClik Cartridge resources

Apidra OptiClik Cartridge Side Effects (in more detail)
Apidra OptiClik Cartridge Use in Pregnancy & Breastfeeding
Apidra OptiClik Cartridge Drug Interactions
Apidra OptiClik Cartridge Support Group
0 Reviews for Apidra OptiClik Cartridge - Add your own review/rating

Apidra Prescribing Information (FDA)

Apidra Monograph (AHFS DI)

Apidra Advanced Consumer (Micromedex) - Includes Dosage Information

Apidra Cartridges MedFacts Consumer Leaflet (Wolters Kluwer)

Apidra Consumer Overview

Compare Apidra OptiClik Cartridge with other medications

Diabetes, Type 1
Diabetes, Type 2

Where can I get more information?

Your pharmacist can provide more information about insulin glulisine.

See also: Apidra OptiClik Cartridge side effects (in more detail)

Wednesday, 30 May 2012

Prohist CD

Generic Name: chlophedianol, phenylephrine, and triprolidine (KLOE fe DYE a nol, FEN il EFF rin, and trye PROE li deen)

Brand Names: Prohist CD

What is Prohist CD (chlophedianol, phenylephrine, and triprolidine)?

Chlophedianol is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Triprolidine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

The combination of chlophedianol, phenylephrine, and triprolidine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion caused by allergies, the common cold, or the flu.

Chlophedianol, phenylephrine, and triprolidine will not treat a cough that is caused by smoking, asthma, or emphysema.

Chlophedianol, phenylephrine, and triprolidine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Prohist CD (chlophedianol, phenylephrine, and triprolidine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use cough or cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

What should I discuss with my healthcare provider before taking Prohist CD (chlophedianol, phenylephrine, and triprolidine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use cough or cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

To make sure you can safely use this medicine, tell your doctor if you have any of these other conditions:

a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;

diabetes;

liver or kidney disease;

epilepsy or other seizure disorder;

cough with mucus, or cough caused by emphysema or chronic bronchitis;

enlarged prostate or urination problems;

low blood pressure;

pheochromocytoma (an adrenal gland tumor); or

if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

You should not use take chlophedianol, phenylephrine, and triprolidine during the third trimester of pregnancy. Do not use cough or cold medicine without telling your doctor if you are pregnant or plan to become pregnant while using the medicine. Chlophedianol, phenylephrine, and triprolidine may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use cough or cold medicine without telling your doctor if you are breast-feeding a baby.

How should I take Prohist CD (chlophedianol, phenylephrine, and triprolidine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cough or cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Prohist CD (chlophedianol, phenylephrine, and triprolidine)?

This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Ask a doctor or pharmacist before using any other cold, allergy, cough, or sleep medicine. Antihistamines, antitussives, and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant. Drinking alcohol can increase certain side effects of chlophedianol, phenylephrine, and triprolidine. Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlophedianol, phenylephrine, and triprolidine can decrease sweating and you may be more prone to heat stroke.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Prohist CD (chlophedianol, phenylephrine, and triprolidine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medicine and call your doctor at once if you have a serious side effect such as:

fast or uneven heart rate;

chest tightness, wheezing;

severe dizziness or anxiety, feeling like you might pass out;

severe headache, mood changes, hallucinations;

tremor, seizure (convulsions);

easy bruising or bleeding, unusual weakness;

fever;

urinating less than usual or not at all;

feeling short of breath; or

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Less serious side effects may include:

mild dizziness or drowsiness;

mild headache;

dry mouth, nose, or throat;

constipation, upset stomach, loss of appetite;

feeling nervous or restless;

blurred vision; or

sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Prohist CD (chlophedianol, phenylephrine, and triprolidine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlophedianol or triprolidine.

Tell your doctor about all other medicines you use, especially:

atropine (Atreza, Sal-Tropine);

benztropine (Cogentin);

topiramate (Topamax);

zonisamide (Zonegran);

an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), and others;

anti-nausea medications such as belladonna (Donnatal), dimenhydrinate (Dramamine), droperidol (Inapsine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), tolterodine (Detrol), or Urogesic Blue;

bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

ulcer medicine such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and other drugs may interact with chlophedianol, phenylephrine, and triprolidine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Prohist CD resources

Prohist CD Side Effects (in more detail)
Prohist CD Use in Pregnancy & Breastfeeding
Prohist CD Drug Interactions
0 Reviews for Prohist CD - Add your own review/rating

Prohist CD Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Prohist CD with other medications

Cough and Nasal Congestion

Where can I get more information?

Your pharmacist can provide more information about chlophedianol, phenylephrine, and triprolidine.

See also: Prohist CD side effects (in more detail)

Thursday, 24 May 2012

Lialda Delayed-Release Tablets

Pronunciation: me-SAL-a-meen
Generic Name: Mesalamine
Brand Name: Examples include Asacol and Lialda

Lialda Delayed-Release Tablets are used for:

Treating various forms of mild to moderate ulcerative colitis (inflammation of the colon). Lialda Delayed-Release Tablets may also be used for other conditions as determined by your doctor.

Lialda Delayed-Release Tablets are a 5-aminosalicylic acid (5-ASA). It works by preventing the production of substances that cause inflammation of the colon.

Do NOT use Lialda Delayed-Release Tablets if:

you are allergic to any ingredient in Lialda Delayed-Release Tablets, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen), or salicylates (eg, aspirin)

you are younger than 18 years of age and you have the flu or chickenpox, or you have received a live vaccine (eg, varicella, influenza) within the past 6 weeks

you are taking probenecid or sulfinpyrazone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lialda Delayed-Release Tablets:

Some medical conditions may interact with Lialda Delayed-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines (including sulfasalazine), foods, or other substances

if you have had a stroke, bleeding in the brain, or an aneurysm

if you have a history of liver or kidney problems, certain stomach problems (pyloric stenosis), pancreas problems (eg, pancreatitis), Kawasaki syndrome, or a rheumatic (inflammatory) disease (eg, rheumatoid arthritis)

if you have a history of heart problems (eg, inflammation of the sac around your heart)

if you have the flu or chickenpox or have recently received a live vaccine (eg, varicella, influenza)

Some MEDICINES MAY INTERACT with Lialda Delayed-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Gingko biloba extract because side effects, such as increased bleeding, may occur

Corticosteroids (eg, prednisone) because they may decrease Lialda Delayed-Release Tablets's effectiveness

Carbonic anhydrase inhibitors (eg, acetazolamide), insulin, meglitinide antidiabetics (eg, repaglinide), sulfonylureas (eg, glipizide), or valproic acid because the risk of their side effects may be increased by Lialda Delayed-Release Tablets

Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), probenecid, spironolactone, or sulfinpyrazone because their effectiveness may be decreased by Lialda Delayed-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lialda Delayed-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lialda Delayed-Release Tablets:

Use Lialda Delayed-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Lialda Delayed-Release Tablets by mouth with or without food. If stomach upset occurs, take with food or milk to reduce stomach irritation.

Swallow Lialda Delayed-Release Tablets whole. Do not break, crush, or chew before swallowing.

Continue to take Lialda Delayed-Release Tablets even if you feel well. Do not miss any doses.

If you miss a dose of Lialda Delayed-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lialda Delayed-Release Tablets.

Important safety information:

Lialda Delayed-Release Tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Lialda Delayed-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Lialda Delayed-Release Tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Lialda Delayed-Release Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

You may notice undissolved parts of Lialda Delayed-Release Tablets in your stool with some brands of Lialda Delayed-Release Tablets. If this occurs repeatedly, contact your doctor.

Some patients may experience an intolerance reaction to Lialda Delayed-Release Tablets. Signs of intolerance are very similar to symptoms of inflammatory bowel disease. They may include severe or persistent stomach pain or cramping, bloody diarrhea, fever, headache, or rash. If you experience any of these symptoms, contact your doctor right away.

Salicylates have been linked to a serious illness called Reye syndrome. Do not give Lialda Delayed-Release Tablets to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.

Lab tests, including kidney function, liver function, and complete blood cell counts, may be performed while you use Lialda Delayed-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Lialda Delayed-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially blood problems.

Lialda Delayed-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lialda Delayed-Release Tablets while you are pregnant. Lialda Delayed-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Lialda Delayed-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Lialda Delayed-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; gas; headache; mild stomach discomfort or pain; nausea; runny or stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody diarrhea; bloody or coffee ground-like vomit; change in the amount of urine; chest pain; dark urine; fever, chills, or persistent sore throat; severe or persistent headache; severe or sudden stomach pain or cramping; shortness of breath; unusual bruising or bleeding; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Lialda side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; diarrhea; dizziness; drowsiness; fast or difficult breathing; fever; headache; hearing loss; ringing in the ears; seizures; sweating; vomiting of blood; weakness.

Proper storage of Lialda Delayed-Release Tablets:

Store Lialda Delayed-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lialda Delayed-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Lialda Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

Lialda Delayed-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lialda Delayed-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Lialda resources

Lialda Side Effects (in more detail)
Lialda Use in Pregnancy & Breastfeeding
Lialda Drug Interactions
Lialda Support Group
26 Reviews for Lialda - Add your own review/rating

Compare Lialda with other medications

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Wednesday, 23 May 2012

Tylenol Childrens Plus Cough & Sore Throat

Generic Name: acetaminophen and dextromethorphan (a SEET a MIN oh fen and DEX troe me THOR fan)

Brand Names: Children's Triacting, Triaminic Cough & Sore Throat Softchews, Tylenol Cough and Sore Throat Daytime

What is Tylenol Childrens Plus Cough & Sore Throat (acetaminophen and dextromethorphan)?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

The combination of acetaminophen and dextromethorphan is used to treat cough and pain or fever caused by the common cold or flu.

Acetaminophen and dextromethorphan may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Tylenol Childrens Plus Cough & Sore Throat (acetaminophen and dextromethorphan)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you take to see if it contains acetaminophen (sometimes abbreviated as "APAP") or dextromethorphan. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) per day. Dextromethorphan will not treat a cough that is caused by smoking.

What should I discuss with my healthcare provider before taking Tylenol Childrens Plus Cough & Sore Throat (acetaminophen and dextromethorphan)?

Do not take this medication if you are allergic to acetaminophen or dextromethorphan. Do not use a cough medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough medicine before the MAO inhibitor has cleared from your body. Dextromethorphan will not treat a cough that is caused by smoking.

Ask a doctor or pharmacist about taking this medication if you have:

liver disease;

alcoholism or cirrhosis of the liver; or

emphysema or chronic bronchitis.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cough medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Tylenol Childrens Plus Cough & Sore Throat (acetaminophen and dextromethorphan)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cough medicine is usually taken only for a short time until your symptoms clear up.

An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One dose of the oral liquid may contain up to 1000 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure the liquid form of this medication with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink extra fluids while you are taking this medication. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cough medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include dizziness, drowsiness, feeling restless or nervous, diarrhea, loss of appetite, seizure (convulsions), or coma.

What should I avoid while taking Tylenol Childrens Plus Cough & Sore Throat (acetaminophen and dextromethorphan)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen and dextromethorphan are contained in many combination medicines. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen (sometimes abbreviated as "APAP") or dextromethorphan. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) of acetaminophen per day.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough medicine can increase your risk of unpleasant side effects.

Tylenol Childrens Plus Cough & Sore Throat (acetaminophen and dextromethorphan) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

severe dizziness, anxiety, restless feeling, or nervousness;

confusion, hallucinations;

slow, shallow breathing;

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

mild loss of appetite, upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tylenol Childrens Plus Cough & Sore Throat (acetaminophen and dextromethorphan)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

celecoxib (Celebrex);

cinacalcet (Sensipar);

darifenacin (Enablex);

imatinib (Gleevec);

isoniazid;

quinidine (Quinaglute, Quinidex);

ranolazine (Ranexa);

ritonavir (Norvir);

sibutramine (Meridia);

terbinafine (Lamisil);

zidovudine (Retrovir, AZT);

gout medication such as probenecid (Benemid);

medicines to treat high blood pressure;

seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton); or

an antidepressant such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.

This list is not complete and there may be other drugs that can interact with acetaminophen and dextromethorphan. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Tylenol Childrens Plus Cough & Sore Throat resources

Tylenol Childrens Plus Cough & Sore Throat Use in Pregnancy & Breastfeeding
Tylenol Childrens Plus Cough & Sore Throat Drug Interactions
0 Reviews for Tylenol Childrens Plus Cough & Sore Throat - Add your own review/rating

Compare Tylenol Childrens Plus Cough & Sore Throat with other medications

Cold Symptoms
Cough
Pain

Where can I get more information?

Your pharmacist can provide more information about acetaminophen and dextromethorphan.

Tuesday, 22 May 2012

Zoloft

Generic Name: Sertraline Hydrochloride
Class: Selective Serotonin-reuptake Inhibitors
VA Class: CN609
Molecular Formula: C₁₇H₁₇C₁₂N•ClH
CAS Number: 79559-97-0

Suicidality

Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.^e ^f Sertraline is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder.¹ ²³⁵ (See Pediatric Use under Cautions.)

In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressants compared with placebo.^e ^f

Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.^e ^f ^g

Appropriately monitor and closely observe all patients who are started on sertraline therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.¹ ^e ^f ^g (See Worsening of Depression and Suicidality Risk under Cautions.)

Introduction

Antidepressant; selective serotonin-reuptake inhibitor (SSRI).¹ ² ³

Uses for Zoloft

Major Depressive Disorder

Management of major depressive disorder.¹ ³ ⁴ ⁵ ¹⁰ ¹¹ ³³ ⁵⁹ ⁶² ¹⁴⁸ ¹⁴⁹ ¹⁵⁰ ¹⁵¹ ¹⁵² ¹⁵⁸ ¹⁵⁹ ³³⁹ ³⁴¹

Efficacy in hospital settings not established.¹

Obsessive-Compulsive Disorder (OCD)

Management of OCD; reduces but does not completely eliminate obsessions and compulsions.¹ ²⁹ ¹⁵⁶ ²³⁵ ²³⁶

Panic Disorder

Management of panic disorder with or without agoraphobia.¹

Posttraumatic Stress Disorder (PTSD)

Management of PTSD;¹ ² ²⁶⁸ ²⁷⁰ more effective in women than in men.¹

Not effective for combat- or war-related PTSD.² ²⁵⁵

Premenstrual Dysphoric Disorder (PMDD)

Management of PMDD; improves symptoms (e.g., depressed mood, premenstrual anger/irritability) and functional impairment (e.g., difficulty in concentrating, lethargy) associated with this disorder.¹ ¹⁴⁰

Efficacy when used in conjunction with oral contraceptives for the treatment of PMDD is unknown.¹ ¹⁴⁰

Social Phobia

Management of social phobia (social anxiety disorder).¹ ²⁸¹ ²⁸²

Premature Ejaculation

Has been used in the management of premature ejaculation†.⁶⁷ ²¹⁷ ²¹⁸ ²¹⁹

Vascular Headaches

Has been used in the management of vascular headaches† with equivocal efficacy.²²⁰ ²²¹

Zoloft Dosage and Administration

General

Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of sertraline and vice versa.¹ ²⁰⁷ A washout period also is advisable when transferring from another antidepressant (e.g., fluoxetine) to sertraline.¹⁰⁴ ¹⁰⁵ ¹¹¹ ¹⁵⁷ ²²⁹

Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.¹ ^e ^f ^g (See Worsening of Depression and Suicidality Risk under Cautions.)

Sustained therapy may be required; monitor periodically for need for continued therapy.¹

Avoid abrupt discontinuance of therapy.¹ ⁵⁹ ¹⁰⁸ ¹¹⁰ ²⁰⁸ To avoid withdrawal reactions, taper dosage gradually.¹ ⁵⁹ ¹⁰⁸ (See Worsening of Depression and Suicidality Risk under Cautions.)

Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery.¹ ³⁰¹ ³⁰² ³¹⁶ ³¹⁷ (See Fetal/Neonatal Morbidity and Mortality and also see Pregnancy under Cautions.)

Administration

Oral Administration

Administer orally once daily (morning or evening).¹ ³ ⁴ ⁵

With oral concentrate solution, measure doses carefully using the calibrated dropper provided by the manufacturer.¹ (See Sensitivity Reactions under Cautions.) Oral concentrate solution must be diluted just prior to administration.¹ Dilute in 120 mL of water, ginger ale, lemon/lime soda, lemonade, or orange juice just prior to administration; do not mix in advance or use anything other than these liquids.¹

Dosage

Available as sertraline hydrochloride; dosage is expressed in terms of sertraline.¹

Pediatric Patients

OCD

Oral

Children 6–12 years of age: Initially, 25 mg once daily.¹

Adolescents 13–17 years of age: Initially, 50 mg once daily.¹

Dosage may be increased at weekly intervals according to clinical response.¹ ³ ⁵ ²³⁵

Avoid excessive dosages in children.¹

Optimum duration not established; may require several months of therapy or longer.¹

Adults

Major Depressive Disorder

Oral

Initially, 50–100 mg once daily.¹ ³ ⁴ ⁵ ⁵⁹ ²³⁹ Dosage may be increased at weekly intervals according to clinical response.¹ ³ ⁵ ²³⁹

Optimum duration not established; may require several months of therapy or longer.¹

OCD

Oral

Initially, 50 mg once daily.¹ Dosage may be increased at weekly intervals according to clinical response.¹ ³ ⁵ ²³⁵

Optimum duration not established; may require several months of therapy or longer.¹

Panic Disorder

Oral

Initially, 25 mg once daily.¹ After 1 week, increase to 50 mg once daily.¹ Dosage may be increased at weekly intervals according to clinical response.¹

Optimum duration not established; may require several months of therapy or longer.¹

PTSD

Oral

Initially, 25 mg once daily.¹ After 1 week, increase to 50 mg once daily.¹ Dosage may then be increased at weekly intervals according to clinical response.¹

Optimum duration not established; may require several months of therapy or longer.¹

PMDD

Oral

Initially, 50 mg once daily given continuously throughout the menstrual cycle or just during the luteal phase (i.e., starting 2 weeks prior to the anticipated onset of menstruation and continuing through the first full day of menses).¹

Dosage may be increased in 50-mg increments at the onset of each new menstrual cycle.¹

If a dosage of 100 mg daily has been established with luteal phase dosing, titrate dosage using a 50 mg daily dosage for the first 3 days of each luteal phase dosing period.¹

Optimum duration not established; periodically assess need for dosage adjustment and continued therapy.¹

Social Phobia

Oral

Initially, 25 mg once daily.³⁰⁴ After 1 week, increase to 50 mg once daily.³⁰⁴ Dosage may be increased at weekly intervals according to clinical response.³⁰⁴

Optimum duration not established; may require several months of therapy or longer.¹

Premature Ejaculation†

Oral

25–50 mg daily.²⁷² Alternatively, 25–50 mg daily on an “as needed” basis.²⁷²

Prescribing Limits

Pediatric Patients

OCD

Oral

Maximum 200 mg daily.¹ ³ ⁵

Adults

Major Depressive Disorder

Oral

Maximum 200 mg daily.¹

OCD

Oral

Maximum 200 mg daily.¹ ³ ⁵

Panic Disorder

Oral

Maximum 200 mg daily.¹

PTSD

Oral

Maximum 200 mg daily.¹

PMDD

Oral

Maximum 150 mg daily when administered continuously or 100 mg daily when administered during the luteal phase only.¹

Social Phobia

Oral

Maximum 200 mg daily.¹

Special Populations

Hepatic Impairment

Decreased clearance;¹ ⁸³ ¹³⁷ lower dosages or less frequent administration recommended.¹

Renal Impairment

No dosage adjustments needed.¹ Not substantially removed by dialysis; supplemental doses may be unnecessary after dialysis.¹ ⁸³ ¹⁸⁵

Cautions for Zoloft

Contraindications

Concomitant use with pimozide or an MAO inhibitor.¹ ³⁵ ²⁰⁷ ³²² (See Interactions.)

Concomitant use of sertraline oral concentrate solution (contains alcohol 12%) and disulfiram or other agents likely to produce disulfiram-like reactions (e.g., metronidazole).¹

Known hypersensitivity to sertraline or any ingredient in the formulation.¹

Warnings/Precautions

Warnings

Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patientswith major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.¹ ^e ^f ^g ^h However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.^e ^f ^g

Appropriately monitor and closely observe patients receiving sertraline for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.^e ^f ^g (See Boxed Warning and also see Pediatric Use under Cautions.)

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or maniamay be precursors to emerging suicidality.^f ^g Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.^e ^f ^g If decision is made to discontinue therapy, taper sertraline dosage as rapidly as is feasible but consider risks of abrupt discontinuance.¹ ^f (See General under Dosage and Administration.)

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.¹ ^f

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, OCD) and nonpsychiatric disorders.¹ ^f

Drug Interactions

Concomitant use with MAO inhibitors associated with serious, sometimes fatal reactions, including manifestations resembling serotonin syndrome (e.g., hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes) or neuroleptic malignant syndrome (NMS).¹ (See Serotonin Syndrome under Cautions and also see Contraindications.)

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs) and other serotonergic drugs (e.g., 5-HT₁ receptor agonists [“triptans”]) or drugs that impair serotonin metabolism (e.g., MAO inhibitors).¹ ³²³ Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).¹ ³²³ (See Interactions.)

Bipolar Disorder

May unmask bipolar disorder.¹ ^f (See Activation of Mania/Hypomania under Cautions.) Sertraline is not approved for use in treating bipolar depression.^a

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.¹ ^f

Fetal/Neonatal Morbidity and Mortality

Possible complications, sometimes severe and requiring prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care, in neonates exposed to sertraline, other SSRIs, or SNRIs late in the third trimester; may arise immediately upon delivery.¹ ³⁰¹ ³⁰² ³¹⁴ ³¹⁵ ³¹⁶ ³¹⁷ ³¹⁸

Increased risk of persistent pulmonary hypertension of the newborn (PPHN) in infants exposed to SSRIs during late pregnancy; PPHN is associated with substantial neonatal morbidity and mortality.¹ ³²⁴ ³²⁶

Carefully consider potential risks and benefits of treatment when used during third trimester of pregnancy.¹ ³⁰¹ ³⁰² ³¹⁶ ³¹⁷ ³²⁴ ³²⁶ Consider cautiously tapering dosage during third trimester prior to delivery.¹ ³⁰¹ ³⁰² ³¹⁶ ³¹⁷ (See Pregnancy under Cautions.)

Sensitivity Reactions

Latex Sensitivity

Dropper dispenser provided with oral concentrate solution contains natural latex proteins in the form of dry natural rubber; possible sensitivity reactions in susceptible individuals.¹

General Precautions

Activation of Mania/Hypomania

Possible activation of mania or hypomania.¹ ⁷ ¹² ²⁸ ³⁴ ³⁵ ⁵⁹ ¹⁶⁷ Use with caution in patients with history of mania or hypomania.¹ ⁴ ⁵⁹ ⁶⁰ (See Bipolar Disorder under Cautions.)

Weight Loss

Possible anorexia and weight loss.¹ ⁸ ¹⁰ ¹¹ ³³ ³⁵ Use with caution in patients who may be adversely affected (e.g., underweight patients).¹

Seizures

Limited experience in patients with a history of seizures; use with caution in such patients.¹

Uricosuric Effect

Decrease in serum uric acid concentrations possible.¹ Use with caution in patients who may be adversely affected (e.g., those at risk for acute renal failure).⁶⁰

Concomitant Illnesses

Experience in patients with concomitant diseases is limited.¹ Patients with recent history of MI or unstable heart disease generally were excluded from premarketing clinical studies, but a postmarketing controlled study suggests that sertraline therapy is well tolerated in these patients.¹ ³¹³

Use with caution in patients with altered metabolism or hemodynamics.¹

Hyponatremia

Reported principally in geriatric patients, those receiving concomitant therapy with a diuretic, and in volume depleted patients; reversible following discontinuance of the drug.¹ ²³ ²⁷ ⁶⁹ May be due to SIADH secretion.¹ Monitor serum sodium concentration periodically in geriatric patients.¹²⁸ ²²⁹

Abnormal Bleeding

Possible increased risk of bleeding, including upper GI bleeding;¹ ²⁸⁹ ³¹¹ ³¹² use with caution.¹

Concomitant use of an NSAIA (e.g., aspirin) or warfarin may potentiate such risk.¹ ⁸³ ²⁸⁹ ³¹¹ ³¹² (See Interactions.)

Endocrine Effects

Possible hypothyroidism, elevated serum thyrotropin, and/or reduced serum thyroxine concentrations.⁸¹ ⁹⁶ ⁹⁷ Monitor thyroid function periodically in patients with thyroid disease.⁹⁷

Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT have not been systematically evaluated.¹

Specific Populations

Pregnancy

Category C.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Increased risk of depression relapse observed in women who discontinued antidepressant therapy during pregnancy compared with those who remained on antidepressant therapy.¹ ³²⁴ ³²⁶

Lactation

Distributed into milk;⁹⁹ ²¹⁶ use with caution.¹

Pediatric Use

Safety and efficacy for OCD not established in children <6 years of age.¹ ²³⁵

Safety and efficacy for other disorders (e.g., major depressive disorder, panic disorder, PTSD, PMDD, social phobia) not established in pediatric patients.¹ ³⁰⁴ Results of 2 placebo-controlled trials in children and adolescents with major depressive disorder did not support a claim of efficacy for use of sertraline in pediatric patients with this condition.¹

Adverse effect profile generally similar to that seen in adults.¹ Weight loss, usually slight, reported in children and adolescents receiving sertraline for major depressive disorder; manufacturer recommends periodic monitoring of weight and growth during long-term therapy with sertraline and other SSRIs.¹

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, OCD, or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).¹ ^f However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.^h No suicides occurred in these pediatric trials.¹ ^f ^h

Carefully consider these findings when assessing potential benefits and risks of sertraline for any clinical use.¹ ^e ^f ^g ^h (See Worsening of Depression and Suicidality Risk under Cautions.)

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹ ¹⁰ ¹² (See Hyponatremia under Cautions.)

In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.^e ^f (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Hepatic Impairment

Decreased clearance; use with caution.¹ ¹³⁷ (See Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

Nausea, diarrhea/loose stools, dyspepsia, dry mouth, somnolence, dizziness, insomnia, tremor, ejaculatory delay, sweating.¹ ³ ⁴ ⁵ ¹²

Adverse effects in children are similar to those reported in adults.¹ (See Pediatric Use under Cautions.)

Interactions for Zoloft

Apparently metabolized by multiple CYP isoenzymes, with none contributing more than 40% to overall metabolism.^c Inhibits CYP2D6 and 3A4, but less potent as an inhibitor than many other drugs.¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Potential pharmacokinetic interactions (increased plasma concentrations of CYP2D6 substrates).¹

Clinically important pharmacokinetic interactions with substrates of 3A4 unlikely.¹ ¹⁰⁰

Drugs Affecting Hepatic Microsomal Enzymes

Clinically important pharmacokinetic interactions with inhibitors or inducers of CYP2D6 or 3A4 unlikely.¹ ¹⁰⁰

Drugs Affecting Hemostasis

Potential pharmacologic interaction (increased risk of bleeding) with concomitant use of drugs that affect hemostasis.¹ ⁸³ ²⁸⁹ ³¹¹ ³¹² Use with caution.¹

Protein-bound Drugs

Potential for displacement of sertraline or other protein-bound drugs from binding sites.¹ Monitor patients for potential adverse effects.¹

Drugs Associated with Serotonin Syndrome

Potential pharmacologic (serotonin syndrome) interaction with serotonergic agents.¹ ¹⁷³ ¹⁷⁴ ¹⁷⁵ ¹⁷⁶ ¹⁷⁷ ¹⁸⁹ ²⁰⁷ ³²³ Avoid such use, or use with caution.¹ ¹⁷⁹ ¹⁹⁸ ³²³ (See Serotonin Syndrome under Cautions.)

Specific Drugs

Drug	Interaction	Comments
Alcohol	Does not potentiate cognitive and motor effects of alcohol¹ ³ ¹⁹ ³⁴ ³⁵ ⁸³ ¹⁴⁶	Concomitant use not recommended¹
Antiarrhythmic agents (e.g., encainide, flecainide, propafenone)	Potential for increased plasma antiarrhythmic concentrations; may result in increased risk of serious, potentially fatal, adverse cardiac effects (e.g., cardiac arrhythmias)¹ ¹⁰⁰	Adjust dosages as needed¹
Antidepressants, tricyclic (TCAs) (e.g., desipramine, imipramine)	Decreased TCA metabolism¹ ¹⁸⁶	Monitor plasma TCA concentrations and adjust dosage as needed¹
Atenolol	β-adrenergic blocking activity not affected by sertraline¹ ⁸³ ⁸⁴
Benzodiazepines (e.g., diazepam)	Decreased diazepam clearance¹ ¹³⁶
Carbamazepine	Pharmacokinetic interaction unlikely¹
Cimetidine	Increased AUC, peak concentration, and elimination half-life of sertraline¹
Cisapride	Increased cisapride metabolism¹	Clinical importance unlikely ¹
Clozapine	Increased plasma clozapine concentrations²⁷⁸	Monitor closely; consider reduction in clozapine dosage²⁷⁸
Digoxin	No change in digoxin pharmacokinetics¹ ⁸³ ¹⁷²
Disulfiram or other agents likely to produce disulfiram-like reactions (e.g., metronidazole)	Possible disulfiram reaction due to alcohol content in sertraline oral concentrate solution¹	Concomitant use with sertraline oral concentrate contraindicated¹
Fluoxetine	Potential for serotonin syndrome¹⁰⁴ ¹⁰⁵ ¹¹¹ ¹⁵⁷	Allow appropriate period of time to elapse between discontinuance of fluoxetine and initiation of sertraline and vice versa¹⁰⁴ ¹⁰⁵ ¹¹¹ ¹⁵⁷
5-HT₁ receptor agonists (“triptans”)	Potentially life-threatening serotonin syndrome¹ ¹⁷⁴ ²⁴⁰ ³²³	Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated¹ ³²³
Isoniazid	Potential for serotonin syndrome²⁰⁴
Linezolid	Possible serotonin syndrome¹ ³⁴²	Use with caution¹
Lithium	Possible serotonin syndrome¹ ¹⁷⁴ ¹⁷⁵ ¹⁷⁷ Pharmacokinetic interaction unlikely¹	Use with caution¹ Monitor serum lithium concentrations; adjust dosage accordingly¹
MAO inhibitors (e.g., moclobemide [not commercially available in the US], selegiline)	Potentially fatal serotonin syndrome or NMS¹ ¹⁷⁴ ¹⁷⁷ ¹⁸⁹ ¹⁹² ²⁰⁸	Concomitant use contraindicated¹ Allow at least 2 weeks to elapse between discontinuance of MAO inhibitor and initiation of sertraline and vice versa¹ ¹⁸⁹ ²⁰⁷
NSAIAs (e.g., aspirin)	Increased risk of bleeding¹ ²⁸⁹ ³¹¹ ³¹²	Use with caution¹
Phenytoin	No change in phenytoin pharmacokinetics or pharmacodynamics observed in one study¹ ¹³⁵ However, potential increase in plasma phenytoin concentrations and subsequent toxicity reported with sertraline and other SSRIs³³⁶ Decreased plasma sertraline concentrations reported during concurrent phenytoin therapy³³⁷	Monitor plasma phenytoin concentrations and adjust phenytoin dosage as necessary, particularly in patients with multiple medical conditions and/or those receiving multiple medications concomitantly ¹ ³³⁶
Pimozide	Increased plasma pimozide concentrations; risk of QT prolongation¹ ³²²	Concomitant use contraindicated¹ ³²²
Propranolol	Pharmacokinetic interaction unlikely¹ ⁸³
Sibutramine	Possible serotonin syndrome¹⁷⁷ ¹⁹⁶ ³²³ ³³⁰ ³³¹	Use with caution³²³
SSRIs and SNRIs	Possible serotonin syndrome¹	Avoid concomitant use¹
Thioridazine	Increased plasma thioridazine concentrations; risk of serious, potentially fatal, adverse cardiac effects (e.g., cardiac arrhythmias)²⁶⁹	Concomitant use not recommended²⁶⁹
Tolbutamide	Decreased tolbutamide clearance¹ ¹³⁸	Clinical importance unknown¹
Tramadol	Possible serotonin syndrome¹	Use with caution¹
Tryptophan and other serotonin precursors	Possible serotonin syndrome¹	Concomitant use not recommended¹
Valproic acid	Possible interaction not systematically evaluated¹	Monitor plasma valproate concentrations and adjust valproic acid dosage accordingly¹
Warfarin	Possible increased PT and risk of bleeding¹ ⁸³	Use with caution¹ Monitor PT whenever sertraline is initiated or discontinued¹ ⁸³

Zoloft Pharmacokinetics

Absorption

Bioavailability

Oral bioavailability in humans has not been fully elucidated to date,¹ ⁴ but ranges from 22–36% in animals.⁴ ⁹⁵

Commercially available tablets and oral concentrate solution are bioequivalent.¹

Food

Food increases the extent of absorption.¹ ³

Distribution

Extent

Crosses the blood-brain barrier.³

Distributes into breast milk.¹ ⁹⁹ ²¹⁶

Plasma Protein Binding

Approximately 98% bound to plasma proteins, principally to albumin and α₁-acid glycoprotein.¹ ³ ⁴ ⁵ ⁹⁵

Elimination

Metabolism

Extensively metabolized, probably in the liver to N-desmethylsertraline and several other metabolites.¹ ³ ⁵ ¹⁹ ¹⁰⁰ ²²⁵ Apparently metabolized by multiple CYP isoenzymes, with none contributing more than 40% to overall metabolism.^c

N-Desmethylsertraline is approximately 5–10 times less potent an inhibitor of serotonin reuptake than sertraline.¹ ⁷⁶ ¹⁰⁰

Elimination Route

Excreted in both urine and feces.¹ ⁵

Half-life

Averages approximately 25–26 hours for sertraline and 62–104 hours for N-desmethylsertraline.¹ ³ ⁵

Special Populations

Because sertraline is extensively metabolized by the liver, hepatic impairment can affect the elimination of the drug.¹ ⁸³ ¹³⁷

No clinically important decreases in sertraline clearance observed in patients with renal impairment.¹

Geriatric patients may have reduced sertraline plasma clearance.¹

Stability

Storage

Oral

Concentrate Solution or Tablets

25°C (may be exposed to 15–30°C).¹

ActionsActions

Mechanism of action as an antidepressant is presumed to be linked to potentiation of serotonergic activity in the CNS resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).¹ ³ ¹⁹ ⁵⁹ ⁶² ⁷⁵ ⁷⁶ ⁸² ⁸⁸ ⁹³

Has very weak effects on the reuptake of norepinephrine or dopamine¹ ³ ⁷⁶ and does not exhibit clinically important anticholinergic, antihistaminic, or adrenergic (α₁, α₂, β) blocking activity at usual therapeutic dosages.¹ ³ ⁸² ⁸⁸

Advice to Patients

Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.¹ ^e ^f ^g FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.¹ ^e ^f ^g

Although not shown to affect psychomotor performance in healthy individuals, importance of exercising caution while operating hazardous machinery, including automobile driving, until gain experience with the drug’s effects in the individual patient.¹

Risks associated with concomitant use with alcohol; concomitant use not recommended.¹

Importance of continuing sertraline therapy even if improvement is evident within 1–4 weeks, unless directed otherwise by their clinician.¹

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.¹

Importance of informing patients of risk of serotonin syndrome with concurrent use of sertraline and 5-HT₁ receptor agonists (“triptans”) or other serotonergic agents.¹ ³²³ Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.¹ ³²³

Importance of diluting oral concentrate solution with appropriate liquid just prior to administration.¹

Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Sertraline Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For solution, concentrate	20 mg (of sertraline) per mL*	Zoloft (with alcohol 12%; with calibrated dropper dispenser containing latex rubber)	Pfizer
	Tablets, film-coated	25 mg (of sertraline)*	Zoloft (scored)	Pfizer
		50 mg (of sertraline)*	Zoloft (scored)	Pfizer
		100 mg (of sertraline)*	Zoloft (scored)	Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Sertraline HCl 100MG Tablets (GREENSTONE): 30/$15.99 or 90/$29.97

Sertraline HCl 20MG/ML Concentrate (GREENSTONE): 60/$59.99 or 180/$159.98

Sertraline HCl 25MG Tablets (GREENSTONE): 30/$19.99 or 90/$35.98

Sertraline HCl 50MG Tablets (GREENSTONE): 30/$14.99 or 90/$22.97

Zoloft 100MG Tablets (PFIZER U.S.): 30/$131.99 or 90/$361.95

Zoloft 20MG/ML Concentrate (PFIZER U.S.): 60/$108.44 or 180/$310.74

Zoloft 25MG Tablets (PFIZER U.S.): 30/$124.99 or 90/$367.97

Zoloft 50MG Tablet